Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans
Primary Purpose
Traumatic Brain Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light box therapy
Negative Ion Generator
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Veterans
Eligibility Criteria
Inclusion Criteria:
- Veteran
- English-speaking
- Accessible by phone
Exclusion Criteria:
- Decisional impairment
- Macular degeneration
- Bipolar disorder
- Shift work
- Currently using lightbox or negative ion generator
Sites / Locations
- Portland VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Light box
Negative Ion Generator
Arm Description
Commercially available lightbox emitting 10,000 lux of light. Subjects asked to use lightbox everyday for an hour for 4 weeks upon waking.
Commercially available negative ion generator. Subjects asked to use everyday for an hour for 4 weeks upon waking.
Outcomes
Primary Outcome Measures
Change in Insomnia Severity Index (ISI)
Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)
Secondary Outcome Measures
Change in NFL, GFAP, UCH-L1, and total tau
Change in neurofilament light chain (NFL), glial fibrillary acidic protein (GFAP), ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), and total tau
Full Information
NCT ID
NCT03968874
First Posted
May 23, 2019
Last Updated
April 4, 2022
Sponsor
Portland VA Medical Center
Collaborators
Center for Neuroscience and Regenerative Medicine (CNRM)
1. Study Identification
Unique Protocol Identification Number
NCT03968874
Brief Title
Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans
Official Title
Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Portland VA Medical Center
Collaborators
Center for Neuroscience and Regenerative Medicine (CNRM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this project is to determine the effect of morning bright light therapy (MBLT) on sleep in Veterans with traumatic brain injury (TBI). Secondarily, the project aims to identify blood-based brain biomarkers (BBBM) associated with sleep in Veterans.
Specific Aim 1. Determine the effect of MBLT on sleep quality in Veterans (primary outcome).
Specific Aim 2. Determine the effect of MBLT on downstream effectors of improved sleep, including cognition, mood, and quality of life measures in Veterans (exploratory outcomes).
Specific Aim 3. Determine the effect of MBLT on levels of specific BBBM related to sleep, and whether changes in specific BBBM predict response to MBLT (secondary outcome).
This study can now be completed 100% remotely.
Detailed Description
This project will utilize a biobehavioral intervention to improve sleep and apply a novel approach to measuring biomarkers in Veterans with TBI. The investigators will use morning bright light therapy (MBLT) to improve sleep. MBLT acts through intrinsically photosensitive retinal ganglion cells and has pleiotropic effects on sleep, circadian rhythms, cognition, mood, and pain through activation of brain circuits.
MBLT is a simple, cost-effective, home-based sleep intervention. It has been studied in a variety of neuropsychiatric populations, such as seasonal affective disorder, non-seasonal depression, Alzheimer's, Huntington's, Parkinson's disease, and schizophrenia. MBLT is an attractive intervention for TBI as patients typically report multiple concomitant symptoms including alterations in mood and alertness (daytime fatigue). One recent placebo-controlled study using MBLT reported improved fatigue in individuals with TBI. Moreover, MBLT has high patient acceptability and is scalable, owing to its ability to be rapidly implemented in any setting including in the home or in a rehabilitation facility.
To address the substantial limitation of using peripheral biomarkers to understand central pathophysiology in TBI, the investigators have developed a method to use blood-based brain biomarkers (BBBM) to track central pathophysiology and symptomatology of TBI and response to treatment. This method entails isolation of neuronally derived exosomes in peripheral blood. Exosomes are membrane bound structures that, instead of being delivered to lysosomes for destruction, reside in multivesicular bodies, fuse with the plasma membrane, and are exocytosed into extracellular spaces. Within the membrane of exosomes are various proteins present in the cell of origin; thus, the cargo of exosomes reflects the microenvironment from the site of exosome production. Exosomes hold promise in TBI since they can readily cross the blood brain barrier (BBB) and be isolated from peripheral circulation. Studying exosomes allows us to isolate those proteins that are routinely disrupted in patients with TBI and sleep disturbances, and to track changes in accordance with treatment condition over time.
In this project, the investigators will conduct a randomized controlled, single blinded trial in which Veterans with and without TBI will receive MBLT or modified negative ion generator; (see below for modification specifications) for 4-weeks. BBBM will be assessed in conjunction with MBLT/sham and neurobehavioral symptomatology. The investigators hypothesize that: 1) MBLT will be associated with improved sleep, and downstream effectors of improved sleep (i.e., cognition, mood, and quality of life), compared to the sham condition; 2) MBLT will show a correlation between BBBM and improved sleep, and levels of BBBM will predict those that respond to MBLT. This will provide novel insights into how these biomarkers relate to neuronal and behavioral changes following TBI and may inform trajectory of recovery.
The study can be completed 100% remotely, in person, or a combination of the two.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Veterans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Light box
Arm Type
Experimental
Arm Description
Commercially available lightbox emitting 10,000 lux of light. Subjects asked to use lightbox everyday for an hour for 4 weeks upon waking.
Arm Title
Negative Ion Generator
Arm Type
Sham Comparator
Arm Description
Commercially available negative ion generator. Subjects asked to use everyday for an hour for 4 weeks upon waking.
Intervention Type
Device
Intervention Name(s)
Light box therapy
Intervention Description
The intervention is sitting in front of a lightbox for 1 hour in the morning upon waking up.
Intervention Type
Device
Intervention Name(s)
Negative Ion Generator
Intervention Description
The intervention is sitting in front of a modified negative ion generator for 1 hour in the morning upon waking up.
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index (ISI)
Description
Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)
Time Frame
Baseline; after 4 weeks of intervention; and 2 months after the end of intervention
Secondary Outcome Measure Information:
Title
Change in NFL, GFAP, UCH-L1, and total tau
Description
Change in neurofilament light chain (NFL), glial fibrillary acidic protein (GFAP), ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), and total tau
Time Frame
Baseline; after 4 weeks of intervention; and 2 months after the end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Veteran
English-speaking
Accessible by phone
Exclusion Criteria:
Decisional impairment
Macular degeneration
Bipolar disorder
Shift work
Currently using lightbox or negative ion generator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miranda Lim, MD, PhD
Phone
503-220-8262
Ext
57404
Email
lmir@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miranda Lim, MD, PhD
Organizational Affiliation
Portland VA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda M Lim, MD, PhD
Email
lmir@ohsu.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All non-identifiable data will be made available to qualified researchers on request to the study PI.
IPD Sharing Time Frame
Information will be sent as soon as is practical and will be available as long as the PI is available.
IPD Sharing Access Criteria
Legitimate research agenda, including but not limited to request to double-check presented or published results and novel analyses.
Learn more about this trial
Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans
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